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Not Yet RecruitingNCT07471854

Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
42 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

To compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.

Detailed description

Inflammatory acne lesions may result in permanent scars . Atrophic, hypertrophic, and keloidal scars are the categories into which acne scars can be generically divided . Atrophic scarring represents about 75% of acne scars and is subdivided into icepick, rolling, and boxcar scars . Currently, there is no standard treatment for atrophic acne scars. Various treatment approaches have been used to improve the appearance of acne scars, with varying degrees of success \]. Traditional treatment methods include lasers, platelet-rich plasma (PRP), excisions, skin abrasion, chemical peeling, tissue filling, microneedling, thread lifting, and photodynamic therapy, while emerging therapies such as mesenchymal stem cells (MSCs) and their derivatives are also available . Autologous fat grafting is an alternative modality in managing post acne scarring . In 2013, Tonnard was the first person who described the technique of obtaining nano fat. Its capacity for regeneration is attributable to the adipose tissue-derived stem cells (ADSCs) and stromal vascular fraction (SVF) cells that promote blood vessel formation and the secretion of growth factors that impede fibrosis and inflammation, speed up wound healing, and improve skin texture. Platelet-rich fibrin (PRF), the second-generation platelet concentrate, was developed for the purpose of removing anticoagulants and for better release of growth factors. A rapid and short centrifugation procedure is needed for separation of blood layers before clotting. A fibrin matrix is formed in the platelet-rich layer entrapping platelets and leukocytes in it. This matrix makes the release of growth factors slow and prolonged comparing with PRP . Microneedling (MN) therapy has been used as a treatment for various dermatological conditions, including scar tissue . This technique involves repetitive skin puncture using sterile microneedles to disrupt dermal collagen that connects the scar tissue. The needle will penetrate the stratum corneum and generate small holes with minimal damage to the epidermis. This process will provoke the regeneration of growth factors to stimulate collagen and elastin production . To the best of our knowledge, platelet rich fibrin and microneedling have never been tried with nanofat injection in the treatment of atrophic post acne scars and our study is the first to do so.

Conditions

Interventions

TypeNameDescription
PROCEDUREnanofat injecionpotential donor sites for fat graft including the lower abdomen, flanks, hips and thighs. After injection of 2 cm of lidocaine hydrochloride 2% intradermally at site of entry blade will be stabbed to open access for harvesting cannula to access subcutaneous fat. Tumescent anesthesia will be infiltrated in multidirectional plane to numb the whole area and waiting for 20 minutes, then starting to push the harvesting cannula in and out with slight suction pressure created by pulling the plunger of 20 ml luer-lock syringe, finally subcutaneous fat started to be expelled in the syringe The aspirated fat will be centrifuged at 3000 rpm for 3 min to concentrate fat particles Then the lipoaspirate will be mechanically emulsified using 2.4, 1.4, and 1.2 mm Luer-to-Luer Tulip connectors via 30 mechanical passes between two syringes through each connector, respectively A filtration process will be performed using a special filter containing a mesh with ultra-fine holes to remove debris
PROCEDUREPlatelet rich fibrinPRF will be produced by single spin centrifugation of 10 ml of venous blood collected in plain glass tube without anticoagulant at 700 rpm for 3 min. The upper layer, yellow to orange colored fluid, will be collected as fluid PRF. Approximately, 1 ml Fluid PRF can be separated from 10 ml blood. * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatment. * one side of face will be treated by intradermal injection of fluid PRF. 0.1 mL of fluid PRF will be injected intradermally into the atrophic scars with 1.5 to 2 cm interval using insulin syringe followed by gentle massaging of the treated area. * The treatment will be started immediately after separation of PRF to avoid clot formation. The patients will receive three treatment sessions with 4 weeks interval
PROCEDUREMicroneedlingMicroneedling will be done by Derma electric-pen, and needle cartridge with 12 needles. Needle length will be adjusted at 2.5 mm and speed level 4 (blue color). * 45 min before the session, local anesthetic cream containing mixture of lidocaine and prilocaine will be applied to one side of the face, then will be sterilized by alcohol before starting the treatment. Dermapen will be moved in the four directions, vertically, horizontally, diagonally right and left, over one side of the face without pressing. * The patients will receive three treatment sessions with 4 weeks interval

Timeline

Start date
2026-05-01
Primary completion
2027-05-01
Completion
2027-12-01
First posted
2026-03-13
Last updated
2026-03-18

Source: ClinicalTrials.gov record NCT07471854. Inclusion in this directory is not an endorsement.